510(k) · Cleared
ClearedIndigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indigo Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 23, 1997 after a 446-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 312 later devices descend from it.
- Decided
- Dec 23, 1997
- Review
- 446 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
312 later devices descend from it, 3 citing it directly.
- This deviceK963969 Indigo Portable Laser System with Temperature Feedback -Model Idl…Indigo Medical, Inc. · 1997
- Descendant · cites it directly · 305 of its ownK021724 Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D…Dornier Medtech America, Inc. · 2002
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 3 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 3 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 3 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Showing 5 of 312 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 312 · See all- K021724Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002 · cites it directly305descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 3 generations on263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 3 generations on230descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 3 generations on229descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power… | Indigo Medical, Inc. | 1997 | — |
| +1 | K021724 | Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse… | Dornier Medtech America, Inc. | 2002 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +3 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 0 |
| 2026 | 25 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K955798 | FDA’s K955798 is Igg Immunoturbidimetric & Calibrator Our OCR of the scanned summary read K955798, FDA’s number for Igg Immunoturbidimetric & Calibrator (Randox Laboratories, Ltd.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 4…ent System with Diffuser-Tip™ Fiberoptic Indications for Use: Note: Indigo is requesting the expansion of the indications for use which have already been cleared under K955798 for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft… | 1996 |
What descends from it? (312)
See all 3123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021724 (Dornier Medtech America, Inc., 2002) has gone furthest, with 305 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Note: Indigo is requesting the expansion of the indications for use which have already been cleared under K955798 for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues. The expanded Indications for Use will read as follows: The Indigo 830¢ LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic…
Read the full statement (130 words)
Note: Indigo is requesting the expansion of the indications for use which have already been cleared under K955798 for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
The expanded Indications for Use will read as follows:
The Indigo 830¢ LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963969
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026